BEUDAMED
    FDA Adverse Event Summary report: N

    X-RAY DETECTABLE GAUZE SPONGE

    MDR report key: 31387 · Received March 20, 1996

    Report

    Report Number
    MW4001124
    Date Received
    March 20, 1996
    Report Date
    January 30, 1996
    Manufacturer
    PROFESSIONAL MEDICAL PRODUCTS, INC.
    Product Code
    GDY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING A SURGICAL PROCEDURE, A PIECE OF WOOD APPROX 3" LONG AND 3/4" WIDE WAS FOUND WITH A 4 X 4", 16 PLY SPONGE. THE SPONGE WITH THE WOOD WAS FULL OF BLOOD AND WAS DISCARDED. MFR HAS BEEN CONTACTED FOR AN EXCHANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 X-RAY DETECTABLE GAUZE SPONGE GAUZE SPONGE GDY PROFESSIONAL MEDICAL PRODUCTS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 *